A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes

Uptown Eye Specialists1 site in 1 country103 target enrollmentJuly 1, 2019

ConditionsMCS vs ReLACS Pain Perception Postoperatively First Eye vs Second Eye Early Anesthesia vs Standard Anesthesia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: MCS vs ReLACS
Sponsor: Uptown Eye Specialists
Enrollment: 103
Locations: 1
Primary Endpoint: Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The focus of this study is to assess how pain can be mitigated for patients undergoing cataract surgery through the early application of anesthesia prior to the surgery as compared to the standard timing, and by using the ReLACS cataract surgery technique compared to the standard MCS technique.

Registry

clinicaltrials.gov

Start Date

July 1, 2019

End Date

September 15, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Uptown Eye Specialists

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS)
•Patients who require surgery in both eyes by same surgeon
•Able to understand English and complete a pain assessment

Exclusion Criteria

•Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery
•Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
•Pre-existing uncontrolled glaucoma/high IOP
•Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
•Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
•Patients under 40, severe obesity (BMI \>35)
•Chronic pain/narcotics/Recreational/medical marijuana

Outcomes

Primary Outcomes

Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery

Time Frame: 1 year

The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

Secondary Outcomes

Differences in pain perception between first eye vs second eye(1 year)
Effects of Early vs Standard administration of neurolept anesthesia on pain perception(1 year)